University of Miami
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Clinical Research Nurse 1
role at
University of Miami
Job Summary The Clinical Trials Nurse, Level 1 delivers patient‑family centered care in a culturally competent manner utilizing evidence‑based standards of quality, safety, and service while ensuring population‑specific patient care and compliance with the research protocol in an ambulatory setting. The Clinical Trials Nurse, Level 1 plays a key role in the recruitment of participants and achievement of research objectives, maintaining the integrity and quality of clinical research studies in accordance with practice guidelines, federal and sponsor regulations, and institutional policies and procedures. The nurse practices in accordance with the Scope and Standards of Nursing Practice of the Florida Nursing Practice Act, regulatory requirements, standards of care, and institutional policies and procedures, and performs all steps of the nursing process including assessing/screening, interpreting data, planning, implementing, and evaluating care, coordinating care with other providers, and teaching patients and families.
Job Functions
Provides clinical trial support in the hospital and/or clinic setting to ensure University patients are offered appropriate clinical trials following Good Clinical Practice standards.
Screens patients/patient records to identify potential trial candidates and notifies the treating physician and University Clinical Research Staff.
Assists the Investigator to obtain subject informed consent following the University Clinical Research Staff Informed Consent Process 301‑05, spending time with the patient and family to provide detailed information about the clinical trial and answer questions.
Educates staff and subjects about protocols, treatment, possible side effects, and complications.
Assesses and documents adverse events and concomitant medications; works closely with protocol Clinical Research Staff to ensure Serious Adverse Events are documented and reported per protocol and regulatory requirements.
Assesses and documents the patient’s compliance and response to protocol treatment and collaborates closely with protocol Clinical Research Staff.
Provides University Clinical Research Staff with the Informed Consent Document Form and all source documentation required to determine eligibility and maintain compliance.
Works closely with the Investigator, Investigational Pharmacist, Comprehensive Treatment Unit (CTU) staff and Clinical Research Services (CRS) Senior Manager to review the clinical trial treatment order‑set and individual patient orders within 6 months of hiring.
Provides potential and registered clinical trial patients with contact information to ensure that patients and families have an avenue to direct questions about the clinical trial that they were offered.
Enter applicable research‑related orders and research specific tests and procedures into the chart for the Investigator to sign.
Performs research‑related protocol specific ECGs and simple clinical tasks (research blood draws, vital signs, etc.) according to scope of practice, skills, and competencies.
Provides conduit between physicians, allied health professionals, nursing staff, and clinical trial patients regarding trial‑related issues to maintain a safe environment for the patient while maintaining compliance.
Communicates with the Investigator, patients, families, clinical staff and University Clinical Research Staff to ensure that treatment plans and research related interventions and activities are understood and scheduled appropriately.
Works with the Investigator to ensure all clinical trial procedures are performed according to the protocol.
Receives clinical trial oral medication from pharmacy and administers the drug, documenting appropriately and providing source documents to the protocol University Clinical Research Staff once Oncology Nursing Society (ONS) provider certification card is obtained and competencies are checked.
Performs second chemotherapy order check prior to administration by another clinical trials nurse once ONS provider certification card is obtained and competencies are achieved.
Qualifications
Bachelor’s degree in relevant field, Certification and Graduated from an accredited nursing program
No prior experience required
Current Florida Registered Nurse license
Current American Heart Association (AHA) Basic Life Support (BLS) for healthcare providers Certification
Current American Heart Association (AHA) Advanced Cardiovascular Life Support (ACLS) for healthcare providers Certification
Strong, effective communication skills with patients, families, and clinical team for innovative patient care and trust
Ability to collaborate with peers in the best interest of the patient to provide consistent quality of care
Ability to establish and maintain positive, caring relationships with executives, managers, physicians, non‑physician providers, patients/families and other departments and staff
Demonstrates strong time management skills to prioritize, triage, and act proactively
Ability to uphold professional ethics and maintain patient confidentiality
Knowledgeable on all aspects of patient care including assessing, planning, coordinating, monitoring, and evaluating the patients’ progress through continuum of care
Skill in completing assignments accurately and with attention to detail
Ability to work evenings, nights, and weekends as necessary
Ability to work independently and/or in a collaborative environment
Critical thinking, analytical and problem‑solving abilities required as related to various aspects of the protocol
Good reading, writing, mathematical, organizational and comprehension skills
Demonstrate ability to maintain cooperative working relationships with internal and external units in a clinical research environment
Knowledge, Skills, and Attitudes
Skill in completing assignments accurately and with attention to detail.
Ability to analyze, organize and prioritize work under pressure while meeting deadlines.
Ability to process and handle confidential information with discretion.
Ability to work evenings, nights, and weekends as necessary.
Ability to communicate effectively in both oral and written form.
Ability to work independently and/or in a collaborative environment.
Benefits & Salary The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.
Equal Opportunity Statement The University of Miami is an Equal Opportunity Employer – Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.
Employment Details Job Status: Full time Employee Type: Staff Pay Grade: H11
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Clinical Research Nurse 1
role at
University of Miami
Job Summary The Clinical Trials Nurse, Level 1 delivers patient‑family centered care in a culturally competent manner utilizing evidence‑based standards of quality, safety, and service while ensuring population‑specific patient care and compliance with the research protocol in an ambulatory setting. The Clinical Trials Nurse, Level 1 plays a key role in the recruitment of participants and achievement of research objectives, maintaining the integrity and quality of clinical research studies in accordance with practice guidelines, federal and sponsor regulations, and institutional policies and procedures. The nurse practices in accordance with the Scope and Standards of Nursing Practice of the Florida Nursing Practice Act, regulatory requirements, standards of care, and institutional policies and procedures, and performs all steps of the nursing process including assessing/screening, interpreting data, planning, implementing, and evaluating care, coordinating care with other providers, and teaching patients and families.
Job Functions
Provides clinical trial support in the hospital and/or clinic setting to ensure University patients are offered appropriate clinical trials following Good Clinical Practice standards.
Screens patients/patient records to identify potential trial candidates and notifies the treating physician and University Clinical Research Staff.
Assists the Investigator to obtain subject informed consent following the University Clinical Research Staff Informed Consent Process 301‑05, spending time with the patient and family to provide detailed information about the clinical trial and answer questions.
Educates staff and subjects about protocols, treatment, possible side effects, and complications.
Assesses and documents adverse events and concomitant medications; works closely with protocol Clinical Research Staff to ensure Serious Adverse Events are documented and reported per protocol and regulatory requirements.
Assesses and documents the patient’s compliance and response to protocol treatment and collaborates closely with protocol Clinical Research Staff.
Provides University Clinical Research Staff with the Informed Consent Document Form and all source documentation required to determine eligibility and maintain compliance.
Works closely with the Investigator, Investigational Pharmacist, Comprehensive Treatment Unit (CTU) staff and Clinical Research Services (CRS) Senior Manager to review the clinical trial treatment order‑set and individual patient orders within 6 months of hiring.
Provides potential and registered clinical trial patients with contact information to ensure that patients and families have an avenue to direct questions about the clinical trial that they were offered.
Enter applicable research‑related orders and research specific tests and procedures into the chart for the Investigator to sign.
Performs research‑related protocol specific ECGs and simple clinical tasks (research blood draws, vital signs, etc.) according to scope of practice, skills, and competencies.
Provides conduit between physicians, allied health professionals, nursing staff, and clinical trial patients regarding trial‑related issues to maintain a safe environment for the patient while maintaining compliance.
Communicates with the Investigator, patients, families, clinical staff and University Clinical Research Staff to ensure that treatment plans and research related interventions and activities are understood and scheduled appropriately.
Works with the Investigator to ensure all clinical trial procedures are performed according to the protocol.
Receives clinical trial oral medication from pharmacy and administers the drug, documenting appropriately and providing source documents to the protocol University Clinical Research Staff once Oncology Nursing Society (ONS) provider certification card is obtained and competencies are checked.
Performs second chemotherapy order check prior to administration by another clinical trials nurse once ONS provider certification card is obtained and competencies are achieved.
Qualifications
Bachelor’s degree in relevant field, Certification and Graduated from an accredited nursing program
No prior experience required
Current Florida Registered Nurse license
Current American Heart Association (AHA) Basic Life Support (BLS) for healthcare providers Certification
Current American Heart Association (AHA) Advanced Cardiovascular Life Support (ACLS) for healthcare providers Certification
Strong, effective communication skills with patients, families, and clinical team for innovative patient care and trust
Ability to collaborate with peers in the best interest of the patient to provide consistent quality of care
Ability to establish and maintain positive, caring relationships with executives, managers, physicians, non‑physician providers, patients/families and other departments and staff
Demonstrates strong time management skills to prioritize, triage, and act proactively
Ability to uphold professional ethics and maintain patient confidentiality
Knowledgeable on all aspects of patient care including assessing, planning, coordinating, monitoring, and evaluating the patients’ progress through continuum of care
Skill in completing assignments accurately and with attention to detail
Ability to work evenings, nights, and weekends as necessary
Ability to work independently and/or in a collaborative environment
Critical thinking, analytical and problem‑solving abilities required as related to various aspects of the protocol
Good reading, writing, mathematical, organizational and comprehension skills
Demonstrate ability to maintain cooperative working relationships with internal and external units in a clinical research environment
Knowledge, Skills, and Attitudes
Skill in completing assignments accurately and with attention to detail.
Ability to analyze, organize and prioritize work under pressure while meeting deadlines.
Ability to process and handle confidential information with discretion.
Ability to work evenings, nights, and weekends as necessary.
Ability to communicate effectively in both oral and written form.
Ability to work independently and/or in a collaborative environment.
Benefits & Salary The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.
Equal Opportunity Statement The University of Miami is an Equal Opportunity Employer – Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.
Employment Details Job Status: Full time Employee Type: Staff Pay Grade: H11
#J-18808-Ljbffr